Blog2021-11-17T16:12:08-03:00
  • blog banner

Passarini Blog

UDI for Brazil – ANVISA

UDI for Brazil - ANVISA Published on December 29th, 2021, and effective as of January 10, 2022, ANVISA informed that it will require the UDI (Unique Device Identifier) in the labeling of registered products and marketed in Brazil. The UDI is composed of the UDI-DI [...]

Anvisa Quality System Management

ANVISA Quality System Management Implementation and Maintenance   If you export medical devices to Brazil, getting ANVISA registration is the first step to making them viable in the market.  ANVISA requires you to ensure that all your manufacturing locations meet Brazilian Good Manufacturing Practices (GMP) requirements, the local equivalent of the  [...]

Resolution of the Directive Board (RDC) 432, ANVISA

Resolution of the Directive Board (RDC) 432, November 4th, 2020 - ANVISA ANVISA has published the Resolution of the Directive Board - RDC nº432 to establish the obligation of describing the composition of personal hygiene products, cosmetics, and perfumes in the Portuguese language on the [...]

Resolution of the Directive Board (RDC) 431, ANVISA

Resolution of the Directive Board (RDC) 431, October 31st, 2020 - ANVISA ANVISA has published the Resolution of the Directive Board RDC 431/2020 where establishes the loading of instruction for use on the ANVISA website. The loading is MANDATORY and the holder of the product is [...]

FDA extends the implementation period for the UDI rule for CLASS I

FDA: implementation of the UDI rule The FDA is communicating today through the publication of a new guidance, the second extension of the deadline for compliance with the UDI rule for class I and unclassified devices*, especially because of the COVID-19 pandemic. The Agency believes [...]

Deadline for implementing UDI for CLASS I devices

The DEADLINE for implementing UDI for CLASS I devices before FDA is CLOSE! Under FDA, compliance with the UDI rule for class I devices becomes mandatory as of September 24, 2020. That date that was initially, September 24, 2018, has already been postponed by 2 [...]

Newsletter

Leave your e-mail in the field below to register in our newsletter and receive news and tips from Passarini every week.

    I have read and agree with the Terms of use and Privacy Policy

    Go to Top